Micro-lipo needle devices and use thereof

ABSTRACT

Embodiments of the present invention disclose micro-lipo needle device and methods of making and using the same.

CROSS-REFERENCE TO RELATED APPLICATION

This is a continuation of U.S. application Ser. No. 16/164,183, filedOct. 18, 2018, which is a continuation-in-part of PCT Application No.PCT/US2017/030247, filed Apr. 28, 2017, the teaching of which beingincorporated herein in its entirety by reference.

FIELD OF THE INVENTION

The invention relates generally to biomedical sciences and technologiesand particularly to tissue harvesting and tissue.

BACKGROUND OF THE INVENTION

The transfer of adipose tissue to various regions of the body is arelatively common cosmetic, therapeutic and structural procedureinvolving the harvest of adipose tissue from one location andre-implantation of the harvested and, oftentimes processed tissue, inanother location (see Coleman 1995; and Coleman 2001). While beinglargely used for repair of small cosmetic defects such as facial folds,wrinkles, pock marks and divots, transfer of adipose tissue has recentlybeen used for cosmetic and/or therapeutic breast augmentation andreconstruction (Bircoll and Novack 1987; and Dixon 1988), andaugmentation of the buttocks (Cardenas-Camarena, Lacouture et al. 1999;de Pedroza 2000; and Peren, Gomez et al. 2000).

In the past, adipose tissue grafts and methods of adipose tissuetransfer were plagued with difficulties and side effects includingnecrosis, absorption of the implant by the body, infection (Castello,Barros et al. 1999; Valdatta, Thione et al. 2001), calcifications andscarring (Huch, Kunzi et al. 1998), inconsistent engraftment, (Eremiaand Newman 2000), lack of durability, and other problems arising fromlack of neovascularization and necrosis of the transplanted tissue. Oneof the biggest challenges in adipose tissue transfer is absorption ofthe implant by the body and volume retention of adipose tissue graftsfollowing transfer. When adipose tissue is harvested or washed, thespace between individual pieces of harvested adipose tissue is filled byliquid (e.g., water, blood, tumescent solution, oil). When thistissue/fluid mixture is implanted into a recipient, the liquid portionis rapidly absorbed by the body resulting in loss of volume. The processby which the amount of fluid is removed from the tissue/fluid mixture isfrequently referred to as “drying the adipose tissue” or “dehydratingthe adipose tissue”. The content of red and white blood cells and thelike within an adipose tissue graft can also significantly affect thevolume of graft retained after graft transplantation, due to inductionor exacerbation of an inflammatory response. Another aspect of tissueretention relates to the amount of lipid within the adipose tissuegraft. It understood that the presence of free lipid (meaning lipidsreleased from dead or damaged adipocytes; also referred to as oil) inadipose tissue grafts can result in induction or exacerbation of aninflammatory response with substantial phagocytic activity andconsequent loss of graft volume.

It is also known that mixing unprocessed adipose tissue with aconcentrated population of adipose-derived regenerative cells overcomesmany of the problems associated with adipose tissue grafts and adiposetissue transfer, as described above. Specifically, supplementingunprocessed adipose tissue with concentrated populations ofadipose-derived cells comprising adipose-derived stem cells increasesthe weight, vascularization, and retention of fat grafts. (See U.S. Pat.No. 7,390,484 and co-pending U.S. Patent Application Publication No.2005/0025755, herein expressly incorporated by reference in theirentireties). Adipose tissue fragments supplemented, or mixed, with aconcentrated population of cells including adipose-derived stem cellsexhibit improved neoangiogeneis and perfusion in grafts when compared tounsupplemented grafts of adipose tissue alone in animal models. Further,adipose tissue grafts supplemented with adipose-derived regenerativecells that comprise adipose derived stem cells show increased graftretention and weight over time, when compared to unsupplemented grafts.(See U.S. Patent Application Publication No. 2005/0025755). Further, theprocessing of adipose tissue in a closed, sterile fluid pathway greatlyreduces the chance of infection. The improvement in autologous transferof adipose tissue seen in the animal models described above has alsobeen replicated in human clinical studies. Nevertheless, the isolationand purification of concentrated populations of adipose-derivedregenerative cells comprising adipose-derived stem cells (ADSCs),usually involves a series of washing, digestion, filtration and/orcentrifugation steps, which can reduce the yield of viable cells,require mechanical equipment and specialized clinicians, and/or cancompromise the quality, appearance, longevity, hydration or efficacy ofthe graft.

Additionally, stresses could cause undesirable reactions to harvestedadipose tissues. Such stresses include, for example, exposure toenvironmental pathogens, which are mentioned above, and prolongedpost-harvest storage, etc.

While devices and systems, for example the devices described in U.S.Pat. No. 9,133,431 B2, were developed to address the above issues andneeds, the need for additional approaches to prepare and optimizeadipose tissue grafts and implants and to isolate and/or concentrateadipose-derived regenerative cells remains. The embodiments describedbelow address such the above-identified needs.

SUMMARY OF THE INVENTION

In one aspect of the present invention, it is provided a micro-liponeedle device, which device comprising:

a main housing configured to provide a cavity, which cavity beingconfigured to be communicateble with a vacuum source such that when themain housing is placed on an area of a body the vacuum source generatesa degree of vacuum to cause a volume of skin and fat to be lifted so asto fill up the cavity;

a needle to puncture the skin that has been lifted to fill up thecavity;

a cannula to be inserted through the inner portion of the needle whereinthe cannula is concentric with the needle and constrained to 1dimension, the travel of which being limited such that no harm is doneto a patient receiving the cannula;

a membrane that is configured to seal an entry window of the needle toprevent leakage; and

an optional assembly comprising the needle and the cannula.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the device furthercomprises a vacuum interlock element that prevents the needle fromentering the cavity unless the cavity is under sufficient vacuum toensure the skin being raised into a safe position for liposuction.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the needle andcannula are adapted to form a matched set forming a concentric seal,limiting leakage.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the device furthercomprises a mechanism that is configured to safe-guard travel of theneedle such that the travel of needle only pokes through the dermiswithout further insertion into the fat tissue to allow a cannula topenetrate the dermis.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the mechanismcomprises a track that allows the needle to slide on in 1 dimension.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the mechanismcomprises a spring mechanism to ensure the needle is returned to a safeposition after use.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the membrane is asilicone membrane.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the devicecomprises the assembly, which assembly comprising a needle carriagehousing and a needle carriage, which articulate to allow the cannula tocover a larger volume of fat tissue for liposuction, wherein theassembly is configured to be able to navigate the body in 3 dimensions.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the assemblyfurther comprises a sweep mechanism configured to allow the cannula tosweep over a range of certain degrees.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the sweepmechanism comprises vertical positions to allow harvesting tissue inmultiple planes.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the sweepmechanism comprises detents every 10 degrees and allows the cannula tosweep over a range of 40 degrees.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the sweepmechanism comprises 2 or more vertical positions at anywhere from 2-20mm below the skin to allow harvesting tissue in two planes defined bythe 2 or more vertical positions.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the device is aone-time-use and disposable (“single patient, single use aka SPSU”)device.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the main housingcomprises a linear, flat skin contact side or a curved skin contactside.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the cannua isattached to a tissue filtration/purification system.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the tissuefiltratio/purification system is a Puregraft™ bag or Puregraft™ syringe.

In a second aspect of the present invention, it is provided a method ofmicro-liposuction, comprising:

harvesting a volume of fat tissue from a subject using a micro-liponeedle device of invention.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the devicecomprises:

a main housing configured to provide a cavity, which cavity beingconfigured to be communicateble with a vacuum source such that when themain housing is placed on an area of a body the vacuum source generatesa degree of vacuum to cause a volume of skin and fat to be lifted so asto fill up the cavity;

a needle to puncture the skin that has been lifted to fill up thecavity;

a cannula to be inserted through the inner portion of the needle whereinthe cannula is concentric with the needle and constrained to 1dimension, the travel of which being limited such that no harm is doneto a patient receiving the cannula;

a membrane that is configured to seal an entry window of the needle toprevent leakage; and

an optional assembly comprising the needle and the cannula.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the device furthercomprises a vacuum interlock element that prevents the needle fromentering the cavity unless the cavity is under sufficient vacuum toensure the skin being raised into a safe position for liposuction.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the needle andcannula are adapted to form a matched set forming a concentric seal,limiting leakage.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the device furthercomprises a mechanism that is configured to safe-guard travel of theneedle such that the travel of needle only pokes through the dermiswithout further insertion into the fat tissue to allow a cannula topenetrate the dermis.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the mechanismcomprises a track that allows the needle to slide on in 1 dimension.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the mechanismcomprises a spring mechanism to ensure the needle is returned to a safeposition after use.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the membrane is asilicone membrane.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the devicecomprises the assembly, which assembly comprising a needle carriagehousing and a needle carriage, which articulate to allow the cannula tocover a larger volume of fat tissue for liposuction, wherein theassembly is configured to be able to navigate the body in 3 dimensions.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the assemblyfurther comprises a sweep mechanism configured to allow the cannula tosweep over a range of certain degrees.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the sweepmechanism comprises vertical positions to allow harvesting tissue inmultiple planes.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the sweepmechanism comprises detents every 10 degrees and allows the cannula tosweep over a range of 40 degrees.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the sweepmechanism comprises 2 or more vertical positions at anywhere from 2-20mm below the skin to allow harvesting tissue in two planes defined bythe 2 or more vertical positions.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the main housingcomprises a linear, flat skin contact side or a curved skin contactside.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the device is aone-time-use and disposable SPSU device.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the cannua isattached to a tissue filtration/purification system.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the tissuefiltratio/purification system is a Puregraft™ bag or Puregraft™ syringe.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the subject is ahuman being.

In a further aspect of the present invention, it is provided a method offabricating a micro-lipo needle device, comprising:

providing a design of the micro-lipo needle device;

providing materials and parts to effect the design of the micro-liponeedle device; and

forming the micro-lipo needle device.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the devicecomprises:

a main housing configured to provide a cavity, which cavity beingconfigured to be communicateble with a vacuum source such that when themain housing is placed on an area of a body the vacuum source generatesa degree of vacuum to cause a volume of skin and fat to be lifted so asto fill up the cavity;

a needle to puncture the skin that has been lifted to fill up thecavity;

a cannula to be inserted through the inner portion of the needle whereinthe cannula is concentric with the needle and constrained to 1dimension, the travel of which being limited such that no harm is doneto a patient receiving the cannula;

a membrane that is configured to seal an entry window of the needle toprevent leakage; and

an optional assembly comprising the needle and the cannula.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the device furthercomprises a vacuum interlock element that prevents the needle fromentering the cavity unless the cavity is under sufficient vacuum toensure the skin being raised into a safe position for liposuction.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the needle andcannula are adapted to form a matched set forming a concentric seal,limiting leakage.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the device furthercomprises a mechanism that is configured to safe-guard travel of theneedle such that the travel of needle only pokes through the dermiswithout further insertion into the fat tissue to allow a cannula topenetrate the dermis.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the mechanismcomprises a track that allows the needle to slide on in 1 dimension.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the mechanismcomprises a spring mechanism to ensure the needle is returned to a safeposition after use.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the membrane is asilicone membrane.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the devicecomprises the assembly, which assembly comprising a needle carriagehousing and a needle carriage, which articulate to allow the cannula tocover a larger volume of fat tissue for liposuction, wherein theassembly is configured to be able to navigate the body in 3 dimensions.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the assemblyfurther comprises a sweep mechanism configured to allow the cannula tosweep over a range of certain degrees.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the sweepmechanism comprises vertical positions to allow harvesting tissue inmultiple planes.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the sweepmechanism comprises detents every 10 degrees and allows the cannula tosweep over a range of 40 degrees.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the sweepmechanism comprises 2 or more vertical positions at anywhere from 2-20mm below the skin to allow harvesting tissue in two planes defined bythe 2 or more vertical positions.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the main housingcomprises a linear, flat skin contact side or a curved skin contactside.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the device is aone-time-use and disposable SPSU device.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the cannua isattached to a tissue filtration/purification system.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the tissuefiltratio/purification system is a Puregraft™ bag or Puregraft™ syringe.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a micro-lipo device having a main housing, a needlecarriage housing, a needle carriage, and a vacuum port. FIG. 1B showsthe micro-lipo device of FIG. 1A in more detail.

FIG. 2A shows a 3D printed version of invention device shown withcannula (blue/silver) inserted from right side.

FIG. 2B shows an embodiment of invention device showing articulation ofneedle/cannula. Shown is the left-most position.

FIG. 3 shows a 3D printed and sterile version of micro-lipo needledevice being successfully used on a human subject.

FIGS. 4A-4F show an embodiment of the invention device having a linear,flat skin contact side.

FIGS. 5A-5E show an embodiment of the invention device having a curvedskin contact side.

FIG. 6 shows an embodiment of invention device made and ready for use.

FIG. 7 shows an embodiment of a vacuum interlock element in someembodiments of the invention device.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION Definitions

As used herein, the term “adipose tissue” is used interchangeably withthe term “fat”, the meaning of which is well known to a person ofordinary skill in the art.

As used herein, the term “adipose tissue removal” or “tissue removal” or“harvesting” or “liposuction” are used interchangeably to mean remove anamount of adipose tissue from a live subject such as a male or femalepatient.

As used herein, the term “tissue filtratio/purification system” refersto a device or system used to purify harvested fat tissue or filter offundesirable component(s) from harvested fat tissue. Examples of such atissue filtratio/purification system is a Puregraft™ system or bag asdescribed in U.S. Pat. No. 9,133,431 or a Puregraft™ syringe asdescribed in U.S. patent application Ser. No. 15/422,304, filed on Feb.1, 2017 and U.S. patent application Ser. No. 15/199,773, filed on Jun.30, 2016. The teachings in the patent and patent applications identifiedherein are incorporated in their entirety by reference.

Whenever is used, the term “collapsible” refers to the attribute of amaterial capable of collapsing under pressure or vacuum or capable ofchanging of shape or contour or of deformation in response to pressurechange, and as such, in some embodiments, the term “collapsible” canmean deformable. An example of a material that is collapsible is aplastic or polymeric material forming a bag, e.g., a bag that isdescribed in U.S. patent application Ser. No. 12/771,985, the teachingsof which is incorporated herein by reference in its entirety.

Micro-Lipo Needle Device

In one aspect of the present invention, it is provided a micro-liponeedle device, which device comprising:

a main housing configured to provide a cavity, which cavity beingconfigured to be communicateble with a vacuum source such that when themain housing is placed on an area of a body the vacuum source generatesa degree of vacuum to cause a volume of skin and fat to be lifted so asto fill up the cavity;

a needle to puncture the skin that has been lifted to fill up thecavity;

a cannula to be inserted through the inner portion of the needle whereinthe cannula is concentric with the needle and constrained to 1dimension, the travel of which being limited such that no harm is doneto a patient receiving the cannula;

a membrane that is configured to seal an entry window of the needle toprevent leakage; and

an optional assembly comprising the needle and the cannula.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the device furthercomprises a vacuum interlock element that prevents the needle fromentering the cavity unless the cavity is under sufficient vacuum toensure the skin being raised into a safe position for liposuction.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the needle andcannula are adapted to form a matched set forming a concentric seal,limiting leakage.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the device furthercomprises a mechanism that is configured to safe-guard travel of theneedle such that the travel of needle only pokes through the dermiswithout further insertion into the fat tissue to allow a cannula topenetrate the dermis.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the mechanismcomprises a track that allows the needle to slide on in 1 dimension.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the mechanismcomprises a spring mechanism to ensure the needle is returned to a safeposition after use.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the membrane is asilicone membrane.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the devicecomprises the assembly, which assembly comprising a needle carriagehousing and a needle carriage, which articulate to allow the cannula tocover a larger volume of fat tissue for liposuction, wherein theassembly is configured to be able to navigate the body in 3 dimensions.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the assemblyfurther comprises a sweep mechanism configured to allow the cannula tosweep over a range of certain degrees.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the sweepmechanism comprises vertical positions to allow harvesting tissue inmultiple planes.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the sweepmechanism comprises detents every 10 degrees and allows the cannula tosweep over a range of 40 degrees.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the sweepmechanism comprises 2 or more vertical positions at anywhere from 2-20mm below the skin to allow harvesting tissue in two planes defined bythe 2 or more vertical positions.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the main housingcomprises a linear, flat skin contact side or a curved skin contactside.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the device is aone-time-use and disposable SPSU device.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the cannua isattached to a tissue filtration/purification system.

In some embodiments of the invention device, optionally in combinationwith any of the various embodiments disclosed herein, the tissuefiltratio/purification system is a Puregraft™ bag or Puregraft™ syringe.

In one aspect of the present invention, it is provided a micro-liponeedle device. Such device includes needles and cannula for fat harvest,which can be used independently or together with a liposuction fattransfer system such as a syringe filtration system as described in U.S.patent application Ser. No. 15/422,304, entitled “Liposuction Device andUse thereof”.

In some embodiments, an invention device includes one or more of thefollowing elements:

a large cavity that is designed to lift, via vacuum, the skin and fat tobe liposuctioned. This cavity limits the area of the body that can beliposuctioned, making it safer and less reliant on doctor skill andknowhow. As used herein, the term “large cavity” refers to a dimensionthat is sufficient to allow a desired volume of skin and fat to belifted and liposuctioned, and the dimension defines and limits the areaof the body to be liposuctioned such that the liposuction will not gobeyond the area and the lifted volume of fat, providing a safe-guard toallow the liposuction to be formed with an enhanced safety assurance(see also FIGS. 1A and 1B). In some embodiments, the invention devicecan include a safety valve which allows one to limits the vacuum to acertain degree (e.g., 15 in Hg) to limit skin trauma. The valve can belocated in the vacuum tubing, but could also be part of the unit;

a needle to puncture the skin that has been lifted to fill up thecavity. In some embodiments, the needle can be designed to be part of amechanism that limits its travel for safety. For example, it can be on atrack and can only slide in 1 dimension. In some embodiments, themechanism has a spring to ensure the needle is returned to the safeposition after use. The travel of the needle is designed so it can onlypoke through the dermis, just enough to allow a cannula to penetrate thedermis;

a cannula to be inserted through the inner portion of the needle(concentric). The cannula is then also constrained to 1 dimension (foreand aft), whose travel is limited such that no harm can be done to thepatient. The cannula can only traverse a limited portion of the body,which is constrained in the cavity. The needle and cannula are adaptedto form a matched set forming a concentric seal, limiting leakage. Insome embodiments, while the cannula can only be allowed to move thoughthe needle, the entire needle/cannula assembly can articulate to allowthe cannula to cover more of the body volume to be liposuction (alsoFIGS. 2A and 2B). For example, the device can have a mechanism thatallows the cannula to sweep over a range of 40 degrees (for example,with detents every 10 degrees) and has two vertical positions forharvesting tissue in multiple planes. For example, the device can bemade to have one position at 10 mm below the skin and another at 6 mmbelow the skin. This allows for safe harvesting of tissue without therisk of going too deep. In summary, the needle/cannula can slide in 1dimension, but the assembly can navigate the body in 3 dimensions;

an optional vacuum interlock. Optionally, the device can include avacuum interlock feature (FIG. 7) that prevents the needle from enteringthe cavity unless the cavity is under sufficient vacuum (whichpractically guarantees that the skin has been safely raised intoposition). This interlock will prevent someone from trying to puncturethe skin before it has been lifted into the cavity, or will prevent aneedle prick to an operator or clean-up crew. In some embodiments, aspring (e.g., a stainless compressing spring) can be loaded to theneedle, which is sufficient to keep the needle out of harm's way; and/or

a silicone membrane that seals the needle entry window to preventleakage.

Referring to FIG. 7, a vacuum interlock 13 is provided inside the cavityformed by the main housing 1 and skin of user, the vacuum interlock 13being mounted on a site of ceiling of the main housing with a springelement 13 a. When the vacuum inside the cavity 12 a generated viavacuum port 7 is insufficient, a volume of the adipose tissue lifted upinto the cavity, 12, would be insufficient such that the spring element13 a would stay in an extended state to block the entrance of a needle.Conversely, when the vacuum inside the cavity generated via vacuum port7 is sufficient, a volume of the adipose tissue lifted up into thecavity, 12, would be sufficient such that the spring element 13 a wouldbe pushed-down by the adipose tissue to make room for entrance of theneedle 5.

In some embodiments, all of the above is one-time-use and disposable(single patient, single use aka SPSU), which would avoidcross-contamination among the patients.

Some further embodiments of the invention device are described in FIGS.1-2: FIG. 1A shows a prototype of a micro-lipo needle device having amain housing 1, carriage housing 2, needle carriage 3, and a vacuum port7.

FIG. 1B shows the micro-lipo needle device of FIG. 1A in more detail.Referring to FIG. 1B, the micro-lipo needle device includes thefollowing elements: a main housing 1, a needle carriage housing 2, aneedle carriage 3, a needle carriage washer 4, a lancet point needle 5,a compressing spring 6, a vacuum port 7, a cannula 8, a needle bondingadhesive 9, and a silicone sealing membrane 10.

FIG. 2A shows an embodiment of micro-lipo needle device shown withcannula (blue/silver) inserted from right side. FIG. 2B is themicro-lipo needle device of FIG. 2A showing articulation, 11, ofneedle/cannula.

Method of Use

In a second aspect of the present invention, it is provided a method ofperforming micro-liposuction, comprising:

harvesting a volume of fat tissue from a subject using a micro-liponeedle device of invention.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the devicecomprises:

a main housing configured to provide a cavity, which cavity beingconfigured to be communicateble with a vacuum source such that when themain housing is placed on an area of a body the vacuum source generatesa degree of vacuum to cause a volume of skin and fat to be lifted so asto fill up the cavity;

a needle to puncture the skin that has been lifted to fill up thecavity;

a cannula to be inserted through the inner portion of the needle whereinthe cannula is concentric with the needle and constrained to 1dimension, the travel of which being limited such that no harm is doneto a patient receiving the cannula;

a membrane that is configured to seal an entry window of the needle toprevent leakage; and

an optional assembly comprising the needle and the cannula.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the device furthercomprises a vacuum interlock element that prevents the needle fromentering the cavity unless the cavity is under sufficient vacuum toensure the skin being raised into a safe position for liposuction.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the needle andcannula are adapted to form a matched set forming a concentric seal,limiting leakage.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the device furthercomprises a mechanism that is configured to safe-guard travel of theneedle such that the travel of needle only pokes through the dermiswithout further insertion into the fat tissue to allow a cannula topenetrate the dermis.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the mechanismcomprises a track that allows the needle to slide on in 1 dimension.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the mechanismcomprises a spring mechanism to ensure the needle is returned to a safeposition after use.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the membrane is asilicone membrane.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the devicecomprises the assembly, which assembly comprising a needle carriagehousing and a needle carriage, which articulate to allow the cannula tocover a larger volume of fat tissue for liposuction, wherein theassembly is configured to be able to navigate the body in 3 dimensions.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the assemblyfurther comprises a sweep mechanism configured to allow the cannula tosweep over a range of certain degrees.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the sweepmechanism comprises vertical positions to allow harvesting tissue inmultiple planes.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the sweepmechanism comprises detents every 10 degrees and allows the cannula tosweep over a range of 40 degrees.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the sweepmechanism comprises 2 or more vertical positions at anywhere from 2-20mm below the skin to allow harvesting tissue in two planes defined bythe 2 or more vertical positions.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the main housingcomprises a linear, flat skin contact side or a curved skin contactside.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the device is aone-time-use and disposable SPSU device.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the cannua isattached to a tissue filtration/purification system.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the tissuefiltratio/purification system is a Puregraft™ bag or Puregraft™ syringe.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the subject is ahuman being.

The device of invention can use to remove or harvest adipose tissue froman area of the body. Exemplary procedures of using the device areprovided below:

-   -   1) Prepare patient for liposuction;    -   2) Introduce local anesthesia, if needed;    -   3) Open sterile micro-lipo device of invention. Place on patient        skin in prepared area and (using supplied syringe and tubing)        pump vacuum until resistance is felt and skin is visibly in the        cavity (optionally, connect to vacuum system set to 15 in Hg).    -   4) Attach included harvest syringe (or PG syringe) to the        harvest cannula and set aside.    -   5) Using one hand, drive the needle mechanism into the skin to        puncture (if needle will not move forward, check vacuum of step        3). While the needle is being held in the inserted position,        quickly introduce the cannula through the needle and into the        patient. Release the needle to allow it to exit the patient and        return to the sheathed position.    -   6) Create vacuum in syringe by pulling it open and locking it in        the open position.    -   7) Liposuction patient by gently pulling cannula/syringe back        and forth until syringe is full of lipoaspirate. If necessary,        harvest from another location to fill syringe.    -   8) Remove cannula from patient, release vacuum, and remove        micro-lipo device from patient and discard.    -   9) Apply bandage to needle entry site.    -   10) If using a Puregraft syringe for filtration, follow        instructions to prepare fat for transfer.

FIG. 3 shows that fat tissue harvesting is successfully performed usinga micro-lipo needle device of invention

The micro-lipo device of invention contains a needle for piercing andgaining access to human fat tissue in a safe and controlled fashion. Thedevice of invention can be made to have various shapes designed forremoving small amount of fat tissue from certain specific areas of thebody: for example, under the chin (to reduce “double chin”— see FIGS.5A-5E of the curved device), in the abdomen area (to help create “sixpack” definition—see FIGS. 4A-4F of “linear” device), love handles,pubic area, etc.

The use includes biomedical and cosmetic applications on a subject.Cosmetic applications can be, for example, organ reshaping oraugmentation. Biomedical applications can be, for example, tissuegrafting, and cell therapy or tissue regenerative therapies.

Method of Fabrication

In a further aspect of the present invention, it is provided a method offabricating a micro-lipo needle device, comprising:

providing a design of the micro-lipo needle device;

providing materials and parts to effect the design of the micro-liponeedle device; and forming the micro-lipo needle device.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the devicecomprises:

a main housing configured to provide a cavity, which cavity beingconfigured to be communicateble with a vacuum source such that when themain housing is placed on an area of a body the vacuum source generatesa degree of vacuum to cause a volume of skin and fat to be lifted so asto fill up the cavity;

a needle to puncture the skin that has been lifted to fill up thecavity;

a cannula to be inserted through the inner portion of the needle whereinthe cannula is concentric with the needle and constrained to 1dimension, the travel of which being limited such that no harm is doneto a patient receiving the cannula;

a membrane that is configured to seal an entry window of the needle toprevent leakage; and

an optional assembly comprising the needle and the cannula.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the device furthercomprises a vacuum interlock element that prevents the needle fromentering the cavity unless the cavity is under sufficient vacuum toensure the skin being raised into a safe position for liposuction.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the needle andcannula are adapted to form a matched set forming a concentric seal,limiting leakage.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the device furthercomprises a mechanism that is configured to safe-guard travel of theneedle such that the travel of needle only pokes through the dermiswithout further insertion into the fat tissue to allow a cannula topenetrate the dermis.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the mechanismcomprises a track that allows the needle to slide on in 1 dimension.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the mechanismcomprises a spring mechanism to ensure the needle is returned to a safeposition after use.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the membrane is asilicone membrane.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the devicecomprises the assembly, which assembly comprising a needle carriagehousing and a needle carriage, which articulate to allow the cannula tocover a larger volume of fat tissue for liposuction, wherein theassembly is configured to be able to navigate the body in 3 dimensions.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the assemblyfurther comprises a sweep mechanism configured to allow the cannula tosweep over a range of certain degrees.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the sweepmechanism comprises vertical positions to allow harvesting tissue inmultiple planes.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the sweepmechanism comprises detents every 10 degrees and allows the cannula tosweep over a range of 40 degrees.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the sweepmechanism comprises 2 or more vertical positions at anywhere from 2-20mm below the skin to allow harvesting tissue in two planes defined bythe 2 or more vertical positions.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the main housingcomprises a linear, flat skin contact side or a curved skin contactside.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the device is aone-time-use and disposable SPSU device.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the cannua isattached to a tissue filtration/purification system.

In some embodiments of the invention method, optionally in combinationwith any of the various embodiments disclosed herein, the tissuefiltratio/purification system is a Puregraft™ bag or Puregraft™ syringe.

EXAMPLES Example 1

Designs of exemplary micro-lipo needle devices of invention are shown inFIGS. 1A, 1B, 2A, and 2B.

Example 2

An embodiment of invention is made by 3D printing, which is shown byFIGS. 2A-2B.

Example 3

An embodiment of the invention micro-lipo needle device is used forliposuction in a human subject following the procedures of inventiondescribed above. FIG. 3 shows that liposuction using the micro-liponeedle device is successful.

Example 4

FIGS. 4A-4F show an embodiment of the invention device. FIG. 4A shows anupside down/flip view of an embodiment of invention device, showing amain housing 1 having a linear, flat skin contact side 1A, a needlecarriage housing 2, a needle carriage washer 4 showing a skin facingside 4A, a vacuum port 7, and a cannula 8. FIG. 4D shows a line-drawingdepiction of the upside down/flip view of the embodiment of inventiondevice, showing a main housing 1 having a linear, flat skin contact side1A, a needle carriage housing 2, a needle carriage washer 4 showing askin facing side 4A, a vacuum port 7, and a cannula 8. FIGS. 4B, 4C and4E each show a top-down side view of the embodiment of invention device,showing a main housing 1 having a linear/flat skin contact side 1A, aneedle carriage housing 2, a needle carriage 3, a vacuum port 7, and acannula 8. FIG. 4F shows a line-drawing depiction of a top-down sideview of the embodiment of invention device, showing a main housing 1having a linear, flat skin contact side 1A, a needle carriage housing 2,a needle carriage 3, a vacuum port 7, and a cannula 8.

Example 5

FIGS. 5A-5E show an embodiment of the invention device. FIG. 5A shows anupside down/flip view of an embodiment of invention device, showing amain housing 1 having a curved skin contact side 1B, a needle carriagewasher 4 showing a skin facing side 4A, and a vacuum port 7. FIGS. 5Band 5C each show a top-down side view of the embodiment of inventiondevice, showing a main housing 1 having a curved skin contact side 1B, aneedle carriage housing 2, a needle carriage 3, a vacuum port 7, and acannula 8. FIG. 5D shows a line-drawing depiction of a top-down sideview of the embodiment of invention device, showing a main housing 1having a curved skin contact side 1B, a needle carriage housing 2, aneedle carriage 3, and a cannula 8. FIG. 5E shows a line-drawingdepiction of a top-down view of the embodiment of invention device,showing a main housing 1 having a curved skin contact side 1B, a needlecarriage housing 2, a needle carriage 3, a vacuum port 7, and a cannula8.

Example 6

FIG. 6 shows an embodiment of invention device made and ready for use,its vacuum port being connected to a flexible tubing.

While various embodiments of the present invention have been describedand shown herein, it will be obvious that such embodiments are providedby way of example only. Numerous variations, changes and substitutionsmay be made without departing from the invention herein. Accordingly, itis intended that the invention be limited only by the spirit and scopeof the appended claims.

The teachings of the references, including patents and patent relateddocuments, cited herein are incorporated herein in their entirety to theextent not inconsistent with the teachings herein.

1. A micro-lipo needle device, comprising: a main housing configured toprovide a cavity, which cavity being configured to be communicateblewith a vacuum source such that when the main housing is placed on anarea of a body the vacuum source generates a degree of vacuum to cause avolume of skin and fat to be lifted so as to fill up the cavity; aneedle to puncture the skin that has been lifted to fill up the cavity;a cannula to be inserted through the inner portion of the needle whereinthe cannula is concentric with the needle and constrained to 1dimension, the travel of which being limited such that no harm is doneto a patient receiving the cannula; a membrane that is configured toseal an entry window of the needle to prevent leakage; and an optionalassembly comprising the needle and the cannula. 2-23. (canceled)